Worldwide Clinical Trials is a leading full-service global CRO that works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Learn more about our expertise through informative webinars that address pivotal topics in clinical research. 

The Paris MASH Meeting on September 5th and 6th will unveil the latest knowledge and advancements in MASH research, setting the stage for the future of MASH medicine. Join leading MASH key opinion leaders (KOLs) just a few days later to hear their panel discussion of the critical findings and advancements shared at the meeting and what they believe we can expect as MASH research continues. Whether you are a seasoned professional or new to MASH, this discussion will equip you with the knowledge and tools necessary to excel in MASH research.

Key topics include:
o Greatest takeaways from the Paris MASH meeting
o Epidemiology & public health burden of MASH
o Emerging concepts in liver rehabilitation & improving metabolic health outcomes
o AI application, ethical consideration & care delivery optimization 
o Best practices in disease monitoring of MASH

Register for this webinar to stay on top of the rapidly evolving field of MASH research and gain insights from the leading MASH KOLs. 

HOST:
Michael Betel
President & Founder, Fatty Liver Alliance
Learn more about Michael: https://fattyliver.ca/our-board

PANELISTS:
Attila Timar-Peregrin, MD, PhD, DVProf
Executive Director, Medical Affairs & Therapeutic Area Lead, Digestive Diseases
Worldwide Clinical Trials
Learn more about Dr. Timar-Peregrin: https://www.worldwide.com/about-us/meet-the-team/attila-timar-peregrin/

Jörn Schattenberg, MD
Professor of Medicine & Director of the Metabolic Liver Research Program
University Medical Center Mainz
Learn more about Dr. Schattenberg: https://academicmedicaleducation.com/jorn-m-schattenberg-md. 

Naim Alkhouri, MD, FAASLD
Chief Medical Officer, Chief of Transplant Hepatology, & Director of the Fatty Liver Program
Arizona Liver Health
Learn more about Dr. Alkhouri: https://azliver.com/dr-naim-alkhouri/

Mark Swain, MD
Professor of Medicine, Cumming School of Medicine
University of Calgary
Learn more about Dr. Swain: https://profiles.ucalgary.ca/mark-gordon-swain

Paris MASH Meeting Takeaways: Real-World Applications & Innovations in MASH Research & Care

In the webinar “Countdown to Crunch Time: How Early and Continual Regulatory Engagement Leads to Regulatory and Commercial Success,” industry-leading regulators with extensive experience in both the biopharma and the CRO space engage in a not-to-be-missed, dynamic conversation. Participants will uncover vital strategies for navigating regulatory pathways seamlessly. By avoiding common pitfalls that could jeopardize submission deadlines, attendees will gain invaluable insights into safeguarding project timelines.

Additionally, this webinar will shed light on the often-overlooked advantages of early and continual engagement with regulatory agencies and how proactive collaborative efforts in the early stages can significantly enhance efficiency and mitigate risks. By sharing lessons learned and expert strategies, participants will be well-equipped to streamline their regulatory journey, ensuring overall success.

Register for this webinar today to gain insights into the advantages of early and continual regulatory engagement.

How Early and Continual Regulatory Engagement Leads to Success

In this webinar, you’ll hear from experts dedicated to creating accessible studies that capture the data sponsors need to move to the next stage in product development. Hear from clinical development professionals who have worked with sponsors across therapeutic areas, phases, and modalities to dig into the details of their protocols, examine their application, and ultimately design trials that work for diverse patients. They’ll be joined by a patient advocate who recently collected extensive patient and researcher community data that will be used to inform clinical development for GLUT1 deficiency syndrome. Together, they’ll dive into real-world examples from their work that you can apply to your program, showing how to de-risk your protocol and truly design your trial with the patient in mind.

In this webinar, you’ll learn how to:

Design trials with a patient experience approach
Consider data that is important to patient communities
Examine a protocol for patient experience optimization
Apply real-life examples to your study

See How it’s Done: Case Studies on Patient Experience Design

This webinar discusses the strategic contributions of a contract research organization as a partner to support the clinical development process.

Between the concept of a novel chemical, biological, or advanced therapeutic medicinal product and the commercial debut of a therapeutic entity fall innumerable business decisions. Will a developer pursue an idea to fruition and seek intermittent funding for each aspect of discovery, development, manufacturing, and commercialization? Or will a sponsor opt to bring development to one of several inflection points, at which options for further development — including out-licensing, portfolio pruning, or modifications in program timelines — become viable as an alternative stratagem? Many factors play a role in the decisions, but an awareness of the strategic ramifications of clinical and regulatory insights designed to “de-risk” investment decisions is key to ensuring optimal engagement with investors, partners, and other entities interested in financially supporting, acquiring, or partnering. Indeed, lead identification and candidate optimization including choice of therapeutic target disproportionally influence the earliest stage development programs for small to midsize pharmaceutical companies, representing one of the more significant inflection points in the discovery to development transition.

Facilitating Investment Decisions for Pharmaceutical and Biotechnology Companies

Discover an informative webinar delving into pharmacokinetics (PK) in first-in-human (FIH) studies and how it optimizes the data points in clinical trials. In the ever-evolving landscape of pharmaceutical research, it’s crucial to keep a close eye on the changes in PK in FIH trials over the past decade. These changes hold valuable insights that can significantly impact the success of clinical studies.

The influence of PK data on clinical study decision-making cannot be overstated; it serves as a cornerstone in shaping the direction of drug development. Furthermore, comprehending how PK data gathered in FIH trials can be leveraged to optimize data collection in long-term patient studies is paramount. It also enables researchers to streamline the data points collected, enhancing efficiency and reducing the burden on patients while ensuring that the clinical trial remains robust and informative.

FIH Trial Trends: How far we've come and where we're going with PK data

Compared to traditional oncology trials, complex and adaptive trial designs require more flexibility, precision, and innovation in their execution. In this webinar, clinical development experts will provide an in-depth look into strategic approaches and innovative solutions necessary for navigating these oncology trials. They will offer insights, practical solutions, and progressive strategies to tackle significant issues in regulatory compliance, statistical methodologies, and data management. 

Topics include:
-Strategies for navigating regulatory hurdles
-Project Optimus & key FDA projects and programs
-Considerations for BOIN & Bayesian designs 
-Cohort complexity management

Navigating Complex & Adaptive Oncology Trials: Key Challenges & Solutions

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